CSB-321 Ph 1 in Immunotherapy for the Treatment of Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Cytosite Biopharma Inc.
Study ID
NCT07057349
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Metastatic Cancer
  • Unresectable Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [18F]CSB-321 — DRUG
    \[18F\]CSB-321 is a PET imaging agent that is bound to released granzyme B from T-cells

Study Details

Single-center with the option to expand to multi-center, international, open label, non-randomized, multiple-dose, multi-cohort study, in participants with metastatic or unresectable cancer. Eligible participants will receive an initial injection of \[18F\]CSB-321 followed by PET imaging prior to administration of the I-O therapy and a second and third injection post treatment each with PET imaging. The images will be analyzed for the distribution of radioactivity. Participants will be followed for adverse events up to 3-4 hours post injection. Available clinical, imaging, and histology data will be collected at follow-up to establish the disease progression for evaluation of \[18F\]CSB-321.

Key Dates

Start date
Sep 1, 2025
Status verified
Jun 2025
Primary completion
Sep 30, 2027
Completion
Feb 28, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: [18F]CSB-321 PET Imaging
    All participants will receive up to 3 doses of \[18F\]CSB-321 with the corresponding PET imaging between 40 and 90 minutes of administration

Primary Outcome Measure

The number of clinically significant changes [ Time Frame: 3-4 hours post injection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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